FDA Considers Expanding Definition of Nonprescription Drugs

Getting medicines into the hands of consumers has become troublesome over the last few years. Research shows that for a variety of reasons, 20 percent of patients with prescriptions do not get them filled. In addition, the time or cost required visiting a doctor to receive a prescription or refill often stops patients.

The Food and Drug Administration thinks that some of these doctor visits can be eliminated. It is exploring ways to make drugs for common conditions available as nonprescription products. Under this paradigm, the agency would approve drugs -- that would otherwise require a prescription -- for over-the-counter (OTC) distribution, if certain conditions are followed.

“OTC drugs have had great success in providing consumers with excellent self-care options. But our concept of self-care is limited to conditions that can be self-diagnosed and self-treated based on the information in the drug facts box, combined with common knowledge,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research.

“What we are asking is, should there be more flexibility in the concept of nonprescription drugs? Can we broaden the assistance a consumers gets and increase the types of medicines that might be available over-the-counter,” she added.

The agency is seeking input from consumers, pharmacists, members of the health care community, regulated industry, and insurers on the feasibility of this initiative, and what types of evidence would be needed to demonstrate that certain drugs could be used safely and effectively in an OTC setting.

How it would work

To ensure safe and appropriate use, special conditions would apply to types of nonprescription products. For example, before getting a medication, you might have to talk with a pharmacist, or need to have a diagnostic test. In other cases, you might have to visit a physician to obtain the original prescription, but not to get refills. FDA is also considering whether some drugs could be a prescription drug and a nonprescription drug with conditions of safe use.

Various technologies could support this model. Kiosks in pharmacies or questionnaires on the Internet could help consumers properly diagnose a health condition and select a drug product. Such types of systems could also help consumers decide if the warnings for a drug mean that they should not take a drug or they should not combine it with certain other drugs or foods.

Another scenario for enhancing self-care could involve pharmacists that could help consumers verify their diagnosis, or decide whether the medication is right.

“Pharmacists could also reinforce directions for use,” said Woodcock.

There are a number of potential benefits for consumers from this initiative: an increase in the appropriate use of medication, decreases in health costs, greater access to health screening, easier access to needed medications, and better, more consistent treatment of common conditions.

“We are crafting changes for the future and want to incorporate innovations and new technologies into CDER’s regulatory practices,” said Woodcock. “The rules for nonprescription status were established in an age when widespread access to information technology did not exist. The world is evolving. It is clear there are now many interactive mechanisms that can help consumers through the process of self-diagnosis and medication selection in a much more comprehensive manner than a few words on a fact box.”

Potential Challenges

There are challenges carrying out such an initiative, including reworking FDA rules. “This will require rulemaking. We are gathering information from stakeholders about potential impacts of changing OTC regulations,” said Woodcock.

The initiative also raises concerns about separating patients from appropriate medical care.

“We are talking about the future of electronic health records and other electronic tools such as e-prescriptions and patient portals that evolve. Pharmacy, patients and providers will be linked in new ways. Greater pharmacist involvement could provide an avenue to bring non-adherent individuals back into health care. Methods to inform and link providers could be developed,” said Woodcock.

Topping the list of other potential roadblocks, are: liability concerns, disruption of workflow for often overburdened pharmacists, equipment costs, and questions about health insurance reimbursement.

While FDA, consumer groups, health care associations and other Federal government agencies acknowledge potential issues with this new paradigm, most are willing to move forward.

“We are in the mindset of ‘yes, if’ instead of ‘no, but’, said Tom Menigham, executive vice president, American Pharmacists Association.

(“Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Drug Products Can Be Considered Nonprescription; Public Hearing,” was published in the Federal Register, February 28, 20121, which outlines the entire initiative. Submit either electronic or written comments by May 7, 2012, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov2. All comments should be identified with Docket No. FDA-2012-N-0171, document number 2012-4597)

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